WATCHMAN Device for Stroke Prevention in Atrial Fibrillation

(ASAP-TOO Trial)

No longer recruiting at 99 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Aspirin, Clopidogrel

Disqualifiers: Stroke, Heart failure, Mechanical valve, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the WATCHMAN, designed to reduce stroke risk in individuals with non-valvular atrial fibrillation, a specific type of irregular heartbeat. The trial aims to determine the device's safety and effectiveness, particularly for those unable to take blood thinners. Participants will either receive the WATCHMAN implant (a left atrial appendage closure device) or follow a prescribed medication plan, based on the doctor's decision. Ideal candidates for this trial have experienced non-valvular atrial fibrillation and cannot take typical blood-thinning medications.

As an unphased trial, this study allows participants to contribute to significant research that could lead to new treatment options for those unable to use traditional blood thinners.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be suitable for a specific medication regimen of aspirin and clopidogrel after the device implant. It's best to discuss your current medications with the study team.

What prior data suggests that the WATCHMAN device is safe for stroke prevention in atrial fibrillation?

Research has shown that the WATCHMAN device is generally safe for individuals with non-valvular atrial fibrillation, a type of irregular heartbeat. In past studies, the device demonstrated a very low rate of major side effects. For example, one study found only a 0.45% chance of serious problems within the first week after the procedure, meaning fewer than 5 out of 1,000 people experienced a major issue soon after receiving the device.

Once the device is in place, most individuals can stop taking blood thinners like warfarin, which carry their own risks. Another study found that 87% of patients stopped using warfarin just 45 days after receiving the device.

These findings suggest that the WATCHMAN device is well-tolerated and may be a safe option for those unable to take blood-thinning medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The WATCHMAN Device is unique because it offers a non-drug alternative for stroke prevention in people with atrial fibrillation. Unlike standard treatments like blood thinners, which can carry bleeding risks, the WATCHMAN Device is a small implant that helps prevent clots from forming in the heart. Researchers are excited about this treatment because it provides a mechanical solution with the potential to reduce stroke risk without the ongoing need for medication, offering a new option for patients who cannot tolerate blood thinners.

What evidence suggests that the WATCHMAN device is effective for stroke prevention in atrial fibrillation?

Research has shown that the WATCHMAN Device, which participants in this trial may receive, can lower the risk of stroke in individuals with non-valvular atrial fibrillation (NVAF) who cannot take blood thinners. The PROTECT AF and PREVAIL studies found the device to be safe and effective over five years. The PINNACLE FLX study also reported positive results with a newer version of the WATCHMAN device. These studies suggest that the device can be a suitable option for those needing stroke prevention without regular blood-thinning medications. Meanwhile, the control arm of this trial involves single antiplatelet therapy or no therapy, as determined by the study physician. ^{1 6 7 8 9}

Who Is on the Research Team?

Jacqueline Saw, MD

Principal Investigator

Vancouver General Hospital

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Maurice Buchbinder, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults with non-valvular atrial fibrillation who can't take blood thinners. They must be able to take aspirin and clopidogrel after getting the WATCHMAN device implanted, willing to consent, and commit to follow-up visits. Excluded are those needing certain surgeries soon, with severe heart issues or bleeding disorders, pregnant women, or those in conflicting studies.

Inclusion Criteria

I am legally old enough to participate in this study according to my local laws.

I can and will come back for all needed follow-ups.

Two doctors agree I can't take blood thinners by mouth.

Exclusion Criteria

The subject has a life expectancy of less than two years

My heart's pumping ability is significantly reduced.

I plan to undergo a surgery or procedure within 3 months after getting a WATCHMAN device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the WATCHMAN LAAC Device implant or control treatment with single antiplatelet therapy or no therapy

7 days

1 visit (in-person) for device implantation or control treatment initiation

Follow-up

Participants are monitored for safety and effectiveness, including assessments for stroke, systemic embolism, and major bleeding

5 years

Scheduled follow-up visits as per protocol

What Are the Treatments Tested in This Trial?

Interventions

• Single Antiplatelet Therapy or No Therapy (Control)
• WATCHMAN LAAC Device Implant

Trial Overview The study tests the WATCHMAN Left Atrial Appendage Closure Device's safety and effectiveness in reducing stroke risk without standard blood thinners. Participants will either receive this implant plus a special medication regimen or no therapy as control.

How Is the Trial Designed?

Group I: WATCHMAN (Device) Experimental Treatment 1 Intervention

WATCHMAN LAAC Device implant including modified post-implant drug regimen.

Group II: Control Active Control 1 Intervention

Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

The WATCHMAN device offers a promising alternative to long-term warfarin therapy for patients with atrial fibrillation (AF) who are at high risk for embolic events but may face complications from anticoagulants, supported by medium-term efficacy and safety data.

This review highlights important technical aspects of WATCHMAN implantation, emphasizing its role as a well-studied option for nonvalvular AF patients who require oral anticoagulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation. N Obeyesekere Mbbs Mrcp Fracp Fhrs, DM.[2020]

The WATCHMAN left atrial appendage closure device is designed to reduce the risk of stroke in patients with nonvalvular atrial fibrillation, but initial studies raised safety concerns leading to a 'not approvable' status from the FDA.

In the subsequent PREVAIL trial, while the device was eventually deemed to have benefits that outweigh risks, updated data indicated a higher incidence of ischemic strokes in the WATCHMAN group (13 strokes) compared to the control group (1 stroke), prompting further review of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy. Waksman, R., Pendyala, LK.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6300422/

The Efficacy and Safety of the WATCHMAN Device in LAA ... It is suggested that Watchman device implantation is effective and safe in high-risk patients with NVAF contraindicated to OACs therapy.

2. watchman.com watchman.com/en-us-hcp/clinical-evidence/additional-trials.html

Completed and active clinical trials ... Learn more about the clinical trials and data for the WATCHMAN LAAC Implant, an alternative to OAC therapy for stroke prevention in NVAF patients.

3. jacc.org jacc.org/doi/10.1016/j.jacc.2017.10.056

Long-Term Results With Left Atrial Appendage Closure In summary, the 5-year combined data from the PROTECT AF and PREVAIL trials confirmed the safety and efficacy of Watchman in stroke prevention. Enrollment ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.026295

Two‐Year Outcomes With a Next‐Generation Left Atrial ... In these final results of the PINNACLE FLX trial, the next‐generation WATCHMAN FLX device demonstrated favorable safety and efficacy outcomes.

5. academic.oup.com academic.oup.com/eurheartj/article/45/32/2914/7716876

Left atrial appendage closure for stroke prevention in atrial ... Surgical LAAC in patients with AF undergoing cardiac surgery reduced the risk of stroke on background of anticoagulation therapy in the LAAOS ...

6. watchman.com watchman.com/en-us-hcp/clinical-evidence/surpass-one-year-results.html

SURPASS real-world data These data continue to support the best-in-class safety profile of the WATCHMAN FLX Implant with a 0.45% major procedural adverse event rate within seven days ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/p130013b.pdf

summary of safety and effectiveness data (ssed) Among subjects successfully implanted with the WATCHMAN. Device, 87% discontinued warfarin therapy by 45 days, and 93% discontinued warfarin ...

8. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.101377

Outcomes of Concomitant Atrial Fibrillation Ablation and ... A total of 102 patients (57.3%) underwent LAAC with the legacy WATCHMAN device, and 76 patients (42.7%) with the WATCHMAN FLX device. Of the ...

9. bostonscientific.com bostonscientific.com/en-EU/products/laac-system/watchman-flx/clinical-evidence.html

Clinical Evidence These data continue to support the best-in-class safety of the WATCHMAN FLX Device with a 0.49% major procedural adverse event rate within 7 days or hospital ...